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New treatment option for Vulvovaginal Candidiasis
Official title Effect of a Multi-strain Probiotic on Recurrent Vulvovaginal Candidiasis
ClinicalTrials.gov ID: NCT06480604
What this study is testing
- What it's testing
- This study evaluates the effect of a multi-strain probiotic on the risk of recurrence and severity of symptoms in females with recurrent vulvovaginal candidiasis (R-VVC).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50, women only. Healthy volunteers may be eligible.
You may be able to join if
- Individuals meeting ALL of the following criteria will be enrolled for the study:
- Premenopausal women aged 18-50 years.
- Women with a culture-confirmed active episode caused by Candida spp. (albicans or non-albicans) reported within 24-48 hours of evidence of clinical...
- Documented history of recurrence of at least 3 VVC episodes in the last 12 months confirmed by vaginal culture /clinical diagnosis.
- Culture growth of Candida spp. causing VVC.
You likely can't join if
- Individuals meeting ANY of the following criteria will be excluded from the study:
- Post-menopausal and peri-menopausal women.
- Pregnant/breast-feeding women.
- Use of oral or vaginal anti-fungal medication in the last 14 days.
- Vaginal culture suggestive of bacterial vaginosis (Nugent's score of 7-10), trichomonas vaginalis or Gardnerella vaginalis.
- Participants found positive for Clotrimazole resistance, by vaginal culture \& sensitivity at screening.
See the full eligibility criteria
- Individuals meeting ALL of the following criteria will be enrolled for the study:
- Premenopausal women aged 18-50 years.
- Women with a culture-confirmed active episode caused by Candida spp. (albicans or non-albicans) reported within 24-48 hours of evidence of clinical symptoms. (No medications should have been initiated before the sample...
- Documented history of recurrence of at least 3 VVC episodes in the last 12 months confirmed by vaginal culture /clinical diagnosis.
- Culture growth of Candida spp. causing VVC.
- Random Capillary Blood Glucose of \< 110mg/dl.
- Willingness to consume the study products for the entire study duration.
- Willing to complete all study procedures and comply with study requirements.
- Willing to abstain from other supplements or medication.
- Ready to give voluntary, written, informed consent to participate in the study.
- Individuals meeting ANY of the following criteria will be excluded from the study:
- Post-menopausal and peri-menopausal women.
- Pregnant/breast-feeding women.
- Use of oral or vaginal anti-fungal medication in the last 14 days.
- Vaginal culture suggestive of bacterial vaginosis (Nugent's score of 7-10), trichomonas vaginalis or Gardnerella vaginalis.
- Participants found positive for Clotrimazole resistance, by vaginal culture \& sensitivity at screening.
- Known allergy to Clotrimazole.
- Women not willing to use any form of vaginal medication during the study.
- Use of vaginal douching.
- Unwillingness to use an appropriate method of contraception.
- Diagnosed with compromised immune system, type I and/or type II diabetes mellitus, or malignancies.
- Use of corticosteroids therapy in the last 30 days.
- Use of oral/systemic antimicrobial therapy in the last 30 days.
- Known allergy to the study products or azoles.
- Individuals with a history of frequent infections requiring antibiotic treatments.
- Participation in another clinical study(ies) in the last 3 months.
- Women who, in the opinion of the Investigator, are considered to be poor clinical attendees or unlikely for any reason to be able to comply with the study.
- Women with uncontrolled hypertension with systolic blood pressure ≥ 140 mm Hg and/or diastolic blood pressure ≥ 90 mm Hg.
- Heavy alcohol drinkers defined as follows: For men, consuming more than 4 drinks on any day or more than 14 drinks/week. For women, consuming more than 3 drinks on any day or more than 7 drinks/week.
- Smokers.
- History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic or neurologic disorders that, in the judgment of the Investigator, would interfere with the participant's...
- Presence of unstable, acutely symptomatic, or life-limiting illness.
- Use of any supplements (includes probiotics, post-biotics, herbal supplements, synbiotics, enzyme supplements, vitamins with probiotics) in the last 30 days.
The study team makes the final eligibility decision.
Where it's taking place
- Vadodara, Gujarat, India
- Nashik, Maharashtra, India
- Pune, Maharashtra, India
- Sopāra, Maharashtra, India
- Vasai, Maharashtra, India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vadodara, Gujarat, India; Nashik, Maharashtra, India; Pune, Maharashtra, India; Sopāra, Maharashtra, India; Vasai, Maharashtra, India. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.